Home › BIOMERICA, INC. › Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]
BIOMERICA, INC. · Model 7063 · UDI-DI 08305900070637
10
510(k) clearances
5
Adverse events
1
Recalls
14
Facilities
Description
The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) in fecal specimens. This assay is intended for in vitro diagnostic use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2002-05-09 | Remel, Inc. | A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.